TPLC - Total Product Life Cycle

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Device	enteroscope and accessories
Regulation Description	Endoscope and accessories.
Definition	To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product Code	FDA
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
ASPERO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BODDINGTONS PLASTICS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM CORPORATON
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	129	129
Failure to Clean Adequately	108	108
Microbial Contamination of Device	34	34
Device Reprocessing Problem	23	23
Contamination	14	14
Pressure Problem	7	7
Corroded	6	6
Crack	6	6
Insufficient Information	6	6
Break	5	5
No Display/Image	5	5
Inflation Problem	5	5
Detachment of Device or Device Component	4	4
Flare or Flash	4	4
Leak/Splash	3	3
Mechanical Problem	3	3
Poor Quality Image	3	3
Complete Blockage	3	3
Contamination /Decontamination Problem	3	3
Residue After Decontamination	3	3
Thermal Decomposition of Device	3	3
Fluid/Blood Leak	2	2
Overheating of Device	2	2
Failure to Deflate	2	2
Melted	2	2
Failure to Calibrate	2	2
Increase in Pressure	2	2
Device Contamination with Chemical or Other Material	2	2
Device Sensing Problem	2	2
Partial Blockage	2	2
Misassembly by Users	2	2
Material Deformation	2	2
Structural Problem	2	2
Obstruction of Flow	2	2
Use of Device Problem	2	2
Material Integrity Problem	2	2
Optical Problem	1	1
Decrease in Pressure	1	1
Device Handling Problem	1	1
Improper Flow or Infusion	1	1
Material Separation	1	1
Degraded	1	1
Overfill	1	1
Material Protrusion/Extrusion	1	1
Activation Failure	1	1
Explosion	1	1
Erratic or Intermittent Display	1	1
Output above Specifications	1	1
Deflation Problem	1	1
Protective Measures Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	229	229
Perforation	52	52
Pancreatitis	49	49
Hemorrhage/Bleeding	32	32
Bowel Perforation	26	26
Abdominal Pain	16	16
Unspecified Hepatic or Biliary Problem	14	14
Laceration(s)	14	14
No Patient Involvement	8	8
Bradycardia	7	7
Laceration(s) of Esophagus	7	7
Hypoxia	6	6
Abrasion	6	6
Unspecified Tissue Injury	5	5
Aspiration Pneumonitis	5	5
Fever	5	5
No Consequences Or Impact To Patient	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Gastrointestinal Hemorrhage	4	4
Inflammation	4	4
Peritonitis	4	4
Abscess	3	3
Unspecified Gastrointestinal Problem	3	3
Respiratory Failure	3	3
Ischemia	3	3
Rupture	3	3
Injury	3	3
Organ Dehiscence	2	2
Pneumonia	2	2
Pain	2	2
Hyperglycemia	2	2
Dyspnea	2	2
Insufficient Information	2	2
Abdominal Distention	2	2
Nausea	2	2
Death	2	2
High Blood Pressure/ Hypertension	2	2
Melena	2	2
Air Embolism	2	2
Pulmonary Embolism	2	2
Bacterial Infection	1	1
Low Blood Pressure/ Hypotension	1	1
Low Oxygen Saturation	1	1
Erosion	1	1
Internal Organ Perforation	1	1
Ulcer	1	1
Capsular Contracture	1	1
Pulmonary Edema	1	1
Bronchospasm	1	1
Stenosis	1	1